FDA grants Akorn approval July 27 for its generic version of Novartis' Zatidor OTC ophthalmic solution (ketotifen fumarate 0.025%), the Buffalo Grove, Ill.-based firm announces in a same-day release. The product, which was approved for OTC use by the agency in October 2006, is indicated for up to 12 hours of relief of itchy eyes due to pollen, ragweed, grass, animal hair and dander, Akorn states (1"The Tan Sheet" Oct. 23, 2006, p. 4). The firm estimates Novartis' branded product posted $36 mil. in sales in 2006. The firm plans to launch the product by October, according to the release. Bausch & Lomb has already announced the release of its Zatidor equivalent (2"The Tan Sheet" July 2, 2007, In Brief)...
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Advanz Pharma would have had to show that the European Commission’s decision to revoke Ocaliva’s conditional marketing approval risked causing serious and irreparable harm, according to lawyers from Van Bael & Bellis.
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A new pilot aims to take Brazil closer to ‘digital transformation.’
If approved, Sanofi’s acoziborole could become the first single-dose oral treatment for sleeping sickness.
Mexico’s drugs regulator will be able to grant quicker drug approvals based on decisions issued by World Health Organization listed authorities and founding ICH members.
Biogen has U-turned on its original decision not to file Qalsody for marketing approval in the UK for treating certain patients with amyotrophic lateral sclerosis. The move appears to have been triggered by a change in the reimbursement pathway agreed for the product.
